Do you want to enroll a diverse patient population in your clinical trial? Are you a sponsor looking to develop a solid clinical trial strategy? Are you looking to develop foundational skills as a clinical research scientist? If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well. Jenn currently serves as the Program Director for cardiovascular studies at Abbott Medical Devices. She has played a key scientific role in some of the larg...
Jan 28, 2021•1 hr•Ep. 35
One of the biggest challenges in clinical study start-up and conduct is “training.” A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more. With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary. In this podcast interview,...
Dec 31, 2020•1 hr 1 min•Ep. 34
Many people tout about technical skills in clinical research. You need to know Microsoft Excel. You need to understand Good Clinical Practice. You need to memorize the FDA guidance documents. Have you ever heard someone talk about soft skills in clinical research? I realized the importance of soft skills after joining Abbott in 2007 as a Clinical Project Manager. When you work with a diverse team, you must master soft skills. Soft skills, also known as “ real skills ”, help you learn, adapt and ...
Nov 24, 2020•50 min•Ep. 33
In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle East and North Africa (MENA region). Maha does a great job of explaining with us how PSPs are set-up, how one can develop a PSP, the lesser known components of a PSP, how to measure a successful PSP, how to evaluate a PSP provider, the interdependence of clinical trials and PSPs in the MENA region and much more. This interview was recorded shortly after the explosion in...
Nov 08, 2020•53 min•Ep. 32
Starting a career in clinical research with little or no experience can be difficult. Equally challenging is for hiring managers to find candidates that are a cultural fit for the organization. In this interview, I invited my close friend and mentor Chris Lewis to talk about his process of attracting, hiring, and retaining talent in clinical research. We talked about the future of the CRA role and what skills are needed to succeed in today’s marketplace. Chris has over 20 years’ experience leadi...
Sep 30, 2020•43 min•Ep. 31
I’m always excited to speak with software entrepreneurs in clinical research and this episode is no excpetion. Our guest on today’s show is Maya Zlatanova, CEO of FindMeCure. Maya and her team are creating a “google” for clinical trials. She is on a mission to make it easy for patients to find ongoing clinical trials She wants to solve patient recruitment challenges enabling patients and doctors to connect with each other She believes in the power of stories, not just facts, something unheard of...
Aug 24, 2020•45 min•Ep. 30
Jun 30, 2020•59 min•Ep. 29
Clinical trial finance is a key area of clinical trials and clinical research. Human beings are innately not good with numbers and clinical trial finance is no exception. Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional. This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of whether they have direct responsibility for clinical trial finances. In this episode, I had the opportun...
May 31, 2020•57 min•Ep. 28
Today we’re in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world. In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials. Mike is the founder and CEO of Medrio . Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision. Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a r...
Apr 30, 2020•1 hr 3 min
In this interview, I had the opportunity to speak with Ahmed Hamouda. Ahmed is the Head of Clinical Operations at RAY-CRO in Egypt and a certified clinical research professional with more than 10 years of experience within the clinical research field. I’ve been intrigued and fascinated by the Middle East and have wondered how trials are conducted in the region. If you’ve been site and country selection meetings trying to determine whether you want to conduct trials in Egypt but have more questio...
Apr 06, 2020•1 hr 9 min•Ep. 26
Ravi Shankar is the founder of FCE Source, a boutique CRO that serves as a strategic partner to medical device companies looking for field clinical engineering support. FCE, which stands for Field Clinical Engineer, is a specialized role that specifically serves medical device trials. FCE is a medical device expert who knows exactly how the medical product needs to be used in the medical setting. In many ways, an FCE is a right hand to the physician. In this interview, Ravi does a fantastic job ...
Feb 15, 2020•1 hr 12 min•Ep. 25
Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem The traditional model involves sponsors and CROs contracting with trial sites and hoping the sites will find and enroll eligible patients. Through her work at monARC Bio, Komathi Stem is flipping the traditional model upside down. In this interview, Komathi shares how patients can now share medical records for clinical research purposes. Pharmaceutical and medical device companies can then leverage this data to easily ide...
Dec 08, 2019•1 hr 3 min•Ep. 24
In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research. Throughout my career, I’ve always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand. Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial s...
Jul 31, 2019•56 min•Ep. 23
In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO). Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the biopharma and medical device industry. At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations. Antoinette graduated from Univers...
Jul 08, 2019•54 min•Ep. 22
In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training. Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan. Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and m...
May 18, 2019•49 min•Ep. 21
Mar 18, 2019•29 min•Ep. 20
Jan 23, 2019•1 hr 2 min•Ep. 19
Karmen Trzupek, MS, CGC, is part of the leadership team at Informed DNA where she is responsible for ocular and rare disease genetics services. In this phenomenal interview, Karmen shares with us the world of genetic testing and the role it plays in clinical trials. Karmen is a certified genetic counselor since 2005. She earned her masters in Genetic Counseling from Northwestern University and a bachelor’s in Microbiology from University of Illinois Prior to joining Informed DNA, Karmen was a ge...
Dec 06, 2018•1 hr 9 min•Ep. 18
In this episode, I share with you strategies and tactical advice on patient recruitment. Patient recruitment is the foundation of any clinical study. If your trial doesn’t enroll the minimum number of patients required per protocol, you or your company cannot get the data you need to prove your trial hypothesis, determine product safety and effectiveness. More importantly, you cannot bring the medical product to the market on time (or possibly never!). This means loss of revenue and profits for ...
Oct 22, 2018•40 min•Ep. 17
Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees. In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human researc...
Oct 01, 2018•1 hr 9 min•Ep. 16
Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division. She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data. Her work focuses on the use of electronic health record systems and claims data for research, with a focus in stu...
Sep 24, 2018•1 hr 25 min•Ep. 15
In this interview, I had the pleasure of speaking with Stephen Smith. Stephen has several years of project management experience in the healthcare industry. His experience isn’t limited to clinical project management. Stephen has served as senior program management director where was the glue between R&D, marketing, clinical and manufacturing teams for rare disease and oncology drugs. Stephen shares his experience working for top-notch organizations such as Genentech, Gilead Sciences, Audentes T...
Aug 18, 2018•1 hr 7 min
In this interview with Dr. Jeffrey Kingsley, we talk about what it takes to start and manage a clinical trial site, the world of site networks, how an investigator can decide whether or not a clinical study is worth their time, volunteering for Association of Clinical Research Professionals (ACRP), Food and Drug Administration (FDA) audits, books and a lot more. Dr. Kingsley is the President and CEO; Institute for the Advancement of Clinical Trials DBA IACT Health and an owner of 11 clinical tri...
Jul 02, 2018•1 hr 14 min
“Just create output. You don't start riding a bike until you take both feet off the ground and push off” - Ryan Jones, CEO, Florence Healthcare Technology is disrupting the clinical research industry. Globally sites, sponsors and CROs are adopting technology to manage risks, to stay competitive, to build a culture that embraces change, to fail fast and to move forward with speed. In this interview with Ryan Jones, the CEO and Co-founder of Florence Healthcare, we discuss a wide range of topics i...
Jun 21, 2018•58 min
“Technology makes our lives easier, but it doesn’t replace people” - Melissa “Liss” Easy The dynamic, engaging Melissa “Liss” Easy is the Founder of clinical operations technology provider DrugDev, which is now part of IQVIA. Early in her career Liss was consulting to a Contract Research Organization and became frustrated by inefficiencies in matching investigators to pharma protocols. She started DrugDev to bring sponsors and investigators together by focusing on the needs of the doctors, givin...
Jun 07, 2018•1 hr•Ep. 11
“I enjoy conversations. It takes you somewhere different” - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40 clini...
May 13, 2018•1 hr 2 min•Ep. 10
“We’re at the threshold of an astounding period in medical discovery” - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data. Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues...
Mar 18, 2018•1 hr 11 min
In this interview, Norm and I dig deep into the business of clinical research. You’ll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more. Hope you enjoy my interview with the all amazing Norman Goldfarb. About Norman Goldfarb Norman Goldfarb is a seasoned executive and leading authority...
Jan 12, 2018•59 min•Ep. 8
“It is important that you start with the big picture” - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air For...
Jan 05, 2018•49 min•Ep. 7
“You have to forgive yourself and not expect perfection” - Robin Eckert In this episode, I had the privilege to talk to Robin Eckert. Robin is an engineer by training who later transitioned into clinical safety and clinical trial management. She is a very accomplished individual who has led complex structural heart medical device trials. Robin is also one of the most creative individuals in the clinical research space. If you’re a gal (or a guy) wanting to transition into clinical research or ch...
Dec 31, 2017•44 min
